Cappella Medical Devices Ltd Receives Regulatory Approval in India to Market its Proprietary Sideguard® Technology Platform
Published: Mar 05, 2012
Up to 30% of all PCI’s [Percutaneous Coronary Interventions] include bifurcation disease. However, a gold standard for therapy involving such lesions does not yet exist. The Sideguard incorporates Cappella’s proprietary stent design and balloon delivery system, offering the interventional cardiologist a solution that, for the first time, provides ostial protection and side branch preservation, thereby enabling enhanced care for patients across a wide range of bifurcation lesions.
David Blossom, VP of Commercial Operations for Cappella said, “This regulatory approval in India represents an important milestone for Cappella Medical. Treating bifurcation disease has always been a challenge for physicians due to the complex anatomy of the coronary sidebranch and the inability of main vessel and work horse stents to address and protect the unique nature of such vasculature.” He added, “Now, clinicians in India, as in a number of other markets, will be able to use Cappella’s Sideguard system, a technology dedicated to bifurcation disease that scaffolds the ostium reducing plaque and carina shift while preserving the sidebranch. India is an important growing, yet underserved, market and Cappella looks forward to introducing its device and technology to clinicians throughout the country.”
The Cappella Sideguard system is currently CE mark approved and is being distributed throughout Europe, South America, and Canada.
Cappella, Inc. is a medical device company that develops novel solutions for the treatment of complex coronary artery disease (CAD) and peripheral artery disease (PAD) focused on its flagship Sideguard technology platform. Cappella’s Sideguard® coronary sidebranch technology offers clinicians a straightforward, effective, and easy to use solution that preserves the sidebranch of diseased coronary arteries by protecting the ostium while minimizing plaque shift. The Sideguard delivery system features a proprietary split-sheath, balloon released, technology that ensures precise placement on the ostial borderline. The Sideguard self-expanding, nitinol, stent promotes continuous wall apposition and positive remodelling and its unique trumpet-shaped design conforms to varying characteristics of the sidebranch ostium. The Cappella Sideguard system is currently CE mark approved and is being distributed throughout Europe, South America, and Canada. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc. For more information, please visit the Cappella Medical Systems website at www.cappella-med.com.
Cappella Medical Devices Ltd
David Blossom, +353 91 758939